Stellarex drug-coated balloon for treatment of femoropopliteal arterial disease—The ILLUMENATE Global Study: 12-Month results from a prospective, multicenter, single-arm study
dc.contributor.author | Schroë, H. | |
dc.contributor.author | Holden, A. | |
dc.contributor.author | Goueffic, Y. | |
dc.contributor.author | Jansen, Shirley | |
dc.contributor.author | Peeters, P. | |
dc.contributor.author | Keirse, K. | |
dc.contributor.author | Ito, W. | |
dc.contributor.author | Vermassen, F. | |
dc.contributor.author | Micari, A. | |
dc.contributor.author | Blessing, E. | |
dc.contributor.author | Jaff, M. | |
dc.contributor.author | Zeller, T. | |
dc.date.accessioned | 2018-12-13T09:16:23Z | |
dc.date.available | 2018-12-13T09:16:23Z | |
dc.date.created | 2018-12-12T02:46:53Z | |
dc.date.issued | 2018 | |
dc.identifier.citation | Schroë, H. and Holden, A. and Goueffic, Y. and Jansen, S. and Peeters, P. and Keirse, K. and Ito, W. et al. 2018. Stellarex drug-coated balloon for treatment of femoropopliteal arterial disease—The ILLUMENATE Global Study: 12-Month results from a prospective, multicenter, single-arm study. Catheterization and Cardiovascular Interventions. 91 (3): pp. 497-504. | |
dc.identifier.uri | http://hdl.handle.net/20.500.11937/73398 | |
dc.identifier.doi | 10.1002/ccd.27348 | |
dc.description.abstract |
© 2017 The Authors. Catheterization and Cardiovascular Interventions Published by Wiley Periodicals, Inc. Objectives: The purpose of this study was to assess the safety and performance of Stellarex Drug-coated balloon (DCB). Background: DCB coatings differ in excipients, paclitaxel dose, and coating morphologies. Due to these differences, a class effect with DCBs has not been demonstrated. Consequently, each DCB needs to be evaluated independently based on its own clinical study results. Methods: The ILLUMENATE Global Study is a prospective, multicenter, single-arm study. Patients with intermittent claudication or ischemic rest pain due to superficial femoral artery (SFA) and/or popliteal peripheral artery disease (PAD) were treated with the Stellarex DCB. The primary efficacy endpoint was primary patency, defined as freedom from restenosis with peak systolic velocity ratio =2.5 or clinically-driven target lesion revascularization (CD-TLR) at 12 months. The primary safety endpoint was freedom from device and procedure-related death through 30 days postprocedure and freedom from target limb major amputation and CD-TLR through 12 months. Results: In total, 417 lesions were treated in 371 patients. The mean lesion length was 7.5 ± 5.3 cm, 40.8% of lesions were severely calcified per core laboratory fluoroscopy criteria and 31.3% were total occlusions. Primary patency by independent duplex core lab evaluation was 81.4% and the freedom from CD-TLR was 94.8% day 365 per Kaplan-Meier estimate. The majority of patients experienced improvements in their Rutherford classification (90.3%) and walking impairment questionnaire score (83.6%) at 12 months compared to baseline. Conclusions: This study validated previous positive findings and confirms the strong safety profile and effectiveness outcomes. | |
dc.title | Stellarex drug-coated balloon for treatment of femoropopliteal arterial disease—The ILLUMENATE Global Study: 12-Month results from a prospective, multicenter, single-arm study | |
dc.type | Journal Article | |
dcterms.source.volume | 91 | |
dcterms.source.number | 3 | |
dcterms.source.startPage | 497 | |
dcterms.source.endPage | 504 | |
dcterms.source.issn | 1522-1946 | |
dcterms.source.title | Catheterization and Cardiovascular Interventions | |
curtin.department | Curtin Medical School | |
curtin.accessStatus | Fulltext not available |
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